EACS2023: 128 CARAVEL: evaluation of real-world antiviral effectiveness and sustainability of the 2-drug regimen Dolutegravir/Lamivudine Fixed Dose Combination (FDC) in treatment-naïve adults and pre-treated adults who are virologicaly suppressed, in routine clinical care, in France. One-year interim analysis results P. Philibert , C. Charpentier , N. Naguleswaran , C. Philippe , L. Roustand , C. Vouillot , L. Hocqueloux Hôpital Européen Marseille, Marseille, France, Hôpital Bichat-Claude Bernard, Paris, France, QUALEES, Paris, France, GSK France, Rueil-Malmaison, France, ViiV Healthcare, Rueil-Malmaison, France, CHU d'Orléans, Orléans, France General data Abstract category: Antiretroviral therapy – observational studies Abstract body Purpose: The primary objective is to describe virological outcome of DTG/3TC for the initial suppression of HIV replication in treatment-naïve people with HIV (TN-PWH), as well as maintaining viral suppression in pre-treated PWH who are virologically suppressed (PT-PWH). Method: CARAVEL is a national, prospective, non-interventional, single-arm, multi-center cohort study with a 3-year follow-up, in which PWH were stratified in two groups: TN-PWH or PT-PWH. To be included, PWH should have started DTG/3TC for the first time and according to Summary of Product Characteristics. Here are presented the 1-year interim analysis results. Results: 49 centers included 304 patients (56 TN-PWH and 248 PT-PWH). Baseline characteristics are presented in Table 1. Main reason for switch is treatment simplification (N=140) and for initiation is following EACS Guidelines (N=45). 46 TN-PWH and 225 PT-PWH had at least 1 VL measure within 6 months of DTG/3TC initiation. Initial suppression (VL <50 copies/ml) was attained for 41 TN-PWH (89.1%) after 6 months of initiation of DTG/3TC, with a mean time to viral suppression of 1.5 (±1.0) months, and no virological failure during the first follow-up year. After switch to DTG/3TC, 216 PT-PWH (96.0%) maintained a VL<50 copies/ml. CD4 cell count was >= 500 cell/mm at 1 year for 74.1% of TN-PWH (N=20) and 78.8% for PTPWH (N=111). DTG/3TC was discontinued for 25 PWH (8.2%), mainly due to patient choice (N=12) and safety reasons (N=10). Mean change in body weight during the 1 follow-up year is +0.7 (±5.6) kg (NS) for TN-PWH (N=31) and +0.1 (±4.3) kg (NS) for PT-PWH (N=152). Conclusions: These results in real life conditions are aligned with those observed in clinical trials in terms of efficacy and safety for both TN-PWH and PT-PWH. General conditions 1. I confirm that I previewed this abstract and that all information is correct. I accept that the content of this abstract cannot be modified or corrected after the submission deadline and I am aware that it will be published exactly as submitted.: Yes 2. I confirm that the submission of the abstract constitutes my consent to publication (e.g. conference website, programmes, other promotions, etc.). : Yes 3. I herewith confirm that the contact details saved in this system are those of the corresponding author, who will be notified about the status of the abstract. The corresponding author is responsible for informing the other authors about the status of the abstract.: Yes 4. I agree that all data provided may be used (saved, stored, processed, transmitted and deleted) in compliance with the privacy policy to provide the services described.: Yes 1 2 3 3 4 5 6 1 2 3 4 5 6 3 st 84 19TH EUROPEAN AIDS CONFERENCE | WARSAW 2023
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